Pancreatic CancerPhase 1NCT00251355
Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Non-Metastatic Pancreatic Cancer
A Phase 1 study testing Gemcitabine, 5-Fluorouracil and Radiation Therapy in people with Pancreatic Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
The purpose of this study is to test a new treatment of pancreatic cancer that cannot be removed by surgery. This treatment is a Phase I dose escalation research study which will combine one drug at increasing doses with a fixed dose of a second drug and radiation therapy. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Gemcitabine, 5-Fluorouracil and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 1998to Aug 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic confirmation of locally unresectable pancreatic adenocarcinoma. Patients with either measurable of evaluable disease are eligible.
- Unresectable, non-metastatic tumors. Unresectable patients include those with local extension of the tumor into adjacent structures and/or nodal metastasis.
- Total bilirubin < 2.0 mg/dl
- AST < 3x ULN
- Serum creatinine < 2.0 mg/dl
- WBC > 3,000/mm3
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- Platelets > 100,000/mm3
- ECOG performance status < or = to 2
- Life expectancy of greater than 12 weeks
Who cannot join
- Evidence of peritoneal seeding by malignancy
- Prior radiation therapy or chemotherapy for pancreatic cancer
- Myocardial infarction in the past 6 months
- Major surgery in past two weeks
- Uncontrolled serious medical or psychiatric illness
- Pregnant or lactating women
- Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase I Study of Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Locally Unresectable Non-Metastatic Pancreatic Cancer
The purpose of this study is to test a new treatment of pancreatic cancer that cannot be removed by surgery. This treatment is a Phase I dose escalation research study which will combine one drug at increasing doses with a fixed dose of a second drug and radiation therapy. The drug that will be used at increasing doses is gemcitabine whereas 5-fluorouracil will remain the same for all patients.
Read the detailed description
- Ultimately we plan to find the maximum tolerated dose of the combination of gemcitabine, 5-fluorouracil and radiation therapy. We also hope to assess the number of people who respond to this therapy and to assess the feasibility of giving intraoperative radiation therapy following gemcitabine, 5-fluorouracil, and external beam radiation therapy.
- A surgical procedure, either laparotomy or laparoscopy, will be required to check the amount of disease before treatment is started.
- All patients will receive the same two chemotherapy drugs and radiation therapy. Both gemcitabine and 5-fluorouracil will begin on the first week of radiation therapy. 5-fluorouracil will be given continuously by intravenous infusion and will continue until the external beam radiation therapy is completed. The gemcitabine will be given (at different doses for each cohort of patients) once per week for seven weeks. Radiation therapy will be given daily for five days for seven weeks. On those days when gemcitabine is given, radiation therapy will be given approximately four hours after the gemcitabine dose.
- Four weeks after completing the radiation therapy and chemotherapy, patients will undergo a scan to check the extent of disease. Following the scan, patients will be considered for a repeat surgical procedure to remove the tumor, if possible. If removal of the tumor is not possible, patients will receive intraoperative radiation therapy.
- After completing the therapy, patients will be seen at least every 3 months for one year. A complete physical exam and CT scan will be done regularly.
- Conditions
- Pancreatic Cancer
- Being tested
- Gemcitabine, 5-Fluorouracil, Radiation Therapy
- Keywords
- gemcitabine, 5-fluorouracil, 5-FU, unresectable pancreatic cancer, non-metastatic pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Gemcitabine, IV bolus administered weekly (weeks 1-6) at least 4 hours before that day's radiation therapy.
5-FluorouracilDrug
5-FU via continuous IV infusion.
Radiation TherapyProcedure or surgery
External Beam Radiotherapy (weeks 1-6), Monday through Friday.
| Study group | Role | What they receive |
|---|---|---|
| 5-FU/gemcitabine/RT | Experimental | Not described Receives: Drug: Gemcitabine; Drug: 5-Fluorouracil; Procedure: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the maximum tolerated dose of weekly gemcitabine when administered with continuous infusion 5-fluorouracil and external beam radiation.
Measured: phase 1
Secondary outcomes (2)
To determine the safety if this regimen
Measured: phase 1
to obtain a preliminary assessment of the efficacy of this regimen in this patient population.
Measured: phase 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2005 (estimated)
- Study startJan 1998
- Primary completionJun 2007
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital
- Responsible party
- Principal investigator, Charles S. Fuchs, MD, Dana-Farber Cancer Institute
- Investigators
- Charles S. Fuchs, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251355
- Sponsor's protocol ID
- 97-105
- Status last verified
- Dec 2016
- First submitted
- 8 Nov 2005
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Locally Unresectable Non-Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00251355
- Acronym / sponsor ID
- 97-105
- Conditions
- Pancreatic Cancer
- Keywords
- gemcitabine, 5-fluorouracil, 5-FU, unresectable pancreatic cancer, non-metastatic pancreatic cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital
- Study start
- Jan 1998
- Primary completion
- Jun 2007 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 10 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test a new treatment of pancreatic cancer that cannot be removed by surgery. This treatment is a Phase I dose escalation research study which will combine one drug at increasing doses with a fixed dose of a second drug and radiation therapy. The drug that will be used at increasing doses is gemcitabine whereas 5-fluorouracil will remain the same for all patients.
Detailed description
- Ultimately we plan to find the maximum tolerated dose of the combination of gemcitabine, 5-fluorouracil and radiation therapy. We also hope to assess the number of people who respond to this therapy and to assess the feasibility of giving intraoperative radiation therapy following gemcitabine, 5-fluorouracil, and external beam radiation therapy.
- A surgical procedure, either laparotomy or laparoscopy, will be required to check the amount of disease before treatment is started.
- All patients will receive the same two chemotherapy drugs and radiation therapy. Both gemcitabine and 5-fluorouracil will begin on the first week of radiation therapy. 5-fluorouracil will be given continuously by intravenous infusion and will continue until the external beam radiation therapy is completed. The gemcitabine will be given (at different doses for each cohort of patients) once per week for seven weeks. Radiation therapy will be given daily for five days for seven weeks. On those days when gemcitabine is given, radiation therapy will be given approximately four hours after the gemcitabine dose.
- Four weeks after completing the radiation therapy and chemotherapy, patients will undergo a scan to check the extent of disease. Following the scan, patients will be considered for a repeat surgical procedure to remove the tumor, if possible. If removal of the tumor is not possible, patients will receive intraoperative radiation therapy.
- After completing the therapy, patients will be seen at least every 3 months for one year. A complete physical exam and CT scan will be done regularly.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5-FU/gemcitabine/RT | Experimental | Drug: Gemcitabine, Drug: 5-Fluorouracil, Procedure: Radiation Therapy |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologic confirmation of locally unresectable pancreatic adenocarcinoma. Patients with either measurable of evaluable disease are eligible.
- Unresectable, non-metastatic tumors. Unresectable patients include those with local extension of the tumor into adjacent structures and/or nodal metastasis.
- Total bilirubin < 2.0 mg/dl
- AST < 3x ULN
- Serum creatinine < 2.0 mg/dl
Key exclusion criteria (7 listed)
- Evidence of peritoneal seeding by malignancy
- Prior radiation therapy or chemotherapy for pancreatic cancer
- Myocardial infarction in the past 6 months
- Major surgery in past two weeks
- Uncontrolled serious medical or psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemcitabineGemcitabine, IV bolus administered weekly (weeks 1-6) at least 4 hours before that day's radiation therapy. | Drug | 5-FU/gemcitabine/RT |
| 5-Fluorouracil5-FU via continuous IV infusion. | Drug | 5-FU/gemcitabine/RT |
| Radiation TherapyExternal Beam Radiotherapy (weeks 1-6), Monday through Friday. | Procedure or surgery | 5-FU/gemcitabine/RT |
Primary outcome
To assess the maximum tolerated dose of weekly gemcitabine when administered with continuous infusion 5-fluorouracil and external beam radiation.
Time frame: phase 1
2 secondary outcomes
To determine the safety if this regimen
Time frame: phase 1
to obtain a preliminary assessment of the efficacy of this regimen in this patient population.
Time frame: phase 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles S. Fuchs, MD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gemcitabine, 5-Fluorouracil and Radiation Therapy in people with Pancreatic Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the maximum tolerated dose of weekly gemcitabine when administered with continuous infusion 5-fluorouracil and external beam radiation. (time frame: phase 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2016.